Efficacy and mechanisms evaluation of remotely delivered Fast Imagery Reversal Script for Trauma release Protocol (FIRST Protocol) vs Waiting List (WL) Controlled group for Post-Traumatic Stress Disorder (PTSD) in UK military veterans (FIRST PETT)

Aims and objectives are to 1) Establish proof of concept of the remotely delivered FIRST protocol. 2) Determine the efficacy of FIRST compared to wait list control at 20 weeks for achieving a Minimal Clinically Important Difference in PTSD symptoms. 3) Understand the impacts of FIRST on mental health and wellbeing. 4) Understand 52-week FIRST maintenance of effect. 5) Determine whether the mechanistic pathways can be understood through established Cognitive science of PTSD. Trial hypothesis and PICOT In UK military veterans (P) the remotely delivered FIRST Protocol (I), compared to waiting list control (C) is clinically and statistically effective in reducing PTSD symptoms by the minimal clinically important difference (O) at 20 weeks (T). Background Post-Traumatic Stress Disorder (PTSD) is a mental health condition which can follow experiencing, or witnessing, events such as threatened or actual death, serious injury or sexual violence. PTSD rates in the general population are 4% but in military veterans it can be up to 17% or higher. For up to 80% of veterans, their PTSD is Complex associated with multiple, or prolonged, traumas. Some veterans find it difficult to seek NHS therapy because it is lengthy and requires trauma recall. NHS therapies are costly which limits availability. Charities and policy makers agree that new PTSD therapies are called for that better meet veterans’ needs. Neurolinguistic programming (NLP) offers brief therapy interventions for people with mental health symptoms, easily delivered by novice psychological care professionals. Several small studies have shown proof of concept but because it is viewed with suspicion by the psychology community no efficacy evidence exists nor little understanding of mechanisms by which it achieves its effects. Understanding mechanistic pathways will help to integrate these brief interventions into standard mental healthcare. The FIRST protocol incorporates NLP and theoretical reconsolidation techniques targeting PTSD symptoms. Methods The trial is a patient-level 1:1 computer randomised controlled trial preceded by a single arm proof of concept study. The trial incorporates a five-month internal pilot, a nested mechanistic experimental study and 52-week maintenance of effect analysis. Over 20 months we will recruit 215 UK military veterans with PTSD and randomise them to immediate FIRST therapy or 4-month waiting list control. FIRST is delivered online via trained, supervised, charity partner therapists. Primary trial outcome is PTSD symptoms assessed by the PCL5. Cognitive outcomes align with mechanistic hypotheses. The final trial follow-up on all outcomes is 20-weeks. Timelines for delivery This is a forty-eight-month (M) trial: M 1-6 are set up, training and KCL ethical approval. M7-12 is proof of concept. The trial commences M 13 with internal pilot and reporting (M 13-17) and recruitment, randomisation and baseline data collection continuing to M 32. Therapy delivery and final 20-week follow up data collection M 14 to 38. Data analysis and maintenance of effect data collection M 39-46. Reporting and dissemination concludes M 47-48. Anticipated impact and dissemination Determining the efficacy and mechanisms of FIRST can lead to significant opportunities for upscaling therapist training and PTSD treatment across NHS. Dissemination will target NHS England and IAPT services for treatment upscaling.